Stroke
Conditions
Keywords
Gait, Brain stimulation, tDCS, Walking
Brief summary
Over four million stroke survivors currently living in the United States are unable to walk independently in the community. To increase the effectiveness of gait rehabilitation, it is critical to develop therapies that are based on an understanding of brain adaptations that occur after stroke. This project will be the first step towards the development of a novel therapeutic approach using brain stimulation to increase walking capacity in stroke survivors and understand the neural mechanisms that are associated with impairment and functional recovery.
Interventions
OTHERtDCS
1 mA of tDCS
OTHERAMT
Ankle motor training
BEHAVIORALTreadmill training
High intensity treadmill training
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Illinois at Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age 50 - 80 years * First ever monohemispheric stroke \> 6 months since onset * Residual hemiparetic gait deficits * Able to walk without an ankle orthotic for 5 minutes at self-paced speed. Handheld assistive device is acceptable.
Exclusion criteria
* Severe osteoporosis * Contracture-limiting range of motion of lower limb * Uncontrolled anti-spasticity medications during the study period * Cardiorespiratory or metabolic diseases (e.g. cardiac arrhythmia, uncontrolled hypertension or diabetes, chronic emphysema) * Unhealed decubiti, persistent infection * Significant cognitive or communication impairment (MMSE \<21), which could impede the understanding of the purpose of procedures of the study or prevent the patient from performing the tracking task. * Lesions pertaining to the brainstem and cerebellum
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in gait speed using 10 meter walk test | Change from baseline to immediately after training and baseline to 3 months follow up | 10-meter walk test: Gait speed will be measured as the average of 3 trials of the 10-m walk test. Participants will be asked to walk at their normal comfortable pace to cover a distance of 10 meters without an AFO (handheld assistive device is acceptable if needed). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in 6 minute walk test | Change from baseline to immediately after training and baseline to 3 months follow up | The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. Participants will be asked to walk at their normal pace for 6 minutes. |
| Change in Berg Balance Scale | Change from baseline to immediately after training and baseline to 3 months follow up | Balance will be measured using the Berg Balance Scale. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function. Tasks such as standing with eyes closed, one leg stance etc are included. |
| Change in Quality of life measures | Change from baseline to immediately after training and baseline to 3 months follow up | QOL will be measured with the Stroke Impact Scale (SIS). The SIS is a stroke-specific self-reported health status measure. |
| Change in cortical excitability of leg muscles using TMS | Change from baseline to immediately after training and baseline to 3 months follow up | Transcranial magnetic stimulation will be used to measure contralateral and ipsilateral corticospinal excitability of the paretic tibialis anterior (TA) using the protocol previously published by the PI Dr. Madhavan. |
Countries
United States
Outcome results
None listed